Surgical Apparatus and Method

ABSTRACT

Surgical method and apparatus for resectioning tissue, preferably lumenal tissue, with a remaining portion of an organ being anastomized with staples or other fastening means, preferably endolumenally. The apparatus may be inserted via a naturally occurring body orifice or a surgical incision and then advanced using either endoscopic or radiological imaging guidance to an area where surgery is to be performed. Under endoscopic or diagnostic imaging guidance the apparatus is positioned so tissue to be resected is manipulated into an inner cavity of the apparatus. The apparatus then cuts the diseased tissue after stapling and retains the diseased tissue within the apparatus. The rent resulting in a border of healthy tissue is anastomosed with surgical staples.

FIELD OF THE INVENTION

This invention relates to surgical apparatus and procedures andspecifically to surgical apparatus and procedures for resectioning,preferably endolumenally, diseased or otherwise undesirable portions oflumenal or other tissue and anastomizing remaining, healthy lumenal orother tissue.

Lexicon

This invention relates to surgical apparatus and procedures andaccordingly, utilizes terminology from the medical and mechanicalengineering fields. To facilitate understanding of this invention byworkers in both fields, the following lexicon is provided; it is to beunderstood that plurals and close variants of these words also have themeanings indicated:

-   -   Anastomose: To connect or join by anastomosis; to communicate by        anastomosis.    -   Anastomosis: The union of parts or branches (such as streams,        blood vessels, or leaf veins) so as to intercommunicate; a        product of anastomosizing, such as a network.    -   Anastomize: To cut in pieces in order to display or examine the        structure and use of the parts; to dissect.    -   Appendicolith: A stone within the appendix.    -   Cannulation: Insertion within a lumen.    -   Endoscopy: Visual inspection of any cavity of the body by means        of an endoscope.    -   Endolumenally: Pertaining to the intralumenal aspect of a hollow        organ.    -   Enterotomy: Cutting completely through the bowel wall        irrespective of the direction of cutting.    -   Laparotomy: Surgical incision through the flank to gain access        to the peritoneal cavity.    -   Lesion: Any pathological or traumatic discontinuity of tissue or        loss of function of a body part.    -   Ligate: To tie or band with a ligature in order to crush or        strangulate.    -   Lumen: The cavity of a hollow organ.    -   Morbid: Of, relating to or characteristic of disease.    -   Mural: Pertaining or occurring in the wall of a cavity.    -   Polypectomy: Surgical removal of a polyp.    -   Resection: Surgical removal of part of an organ or structure.    -   Serosal: Pertaining to or composed of any serous membrane.    -   Sessile: Attached by a base; not pedunculated or stalked.    -   Staple: Tissue ligature or suture.    -   Submucosal: Pertaining to the submucosa; situated beneath the        mucous membrane.    -   Transect: A section made across a long axis; a cross-section;        division by cutting transversely.    -   Transmural: Through the wall of an organ, extending through or        affecting the entire thickness of the wall of an organ or        cavity.

DESCRIPTION OF THE PRIOR ART

Endoscopy studies the intra-lumenal aspects of hollow organs of theupper and lower intestine including the esophagus, stomach and the colonthrough cannulation of the lumen via the mouth or anus.

Endoscopic polypectomy is presently limited to a submucosal resection.The endoscopist is often unable to completely resect a sessile polyp orlesion and therefore the patient is subjected to subsequent definitivesurgery, i.e. resection of the base of the tumor. Endoscopic polypectomycan be used to debunk sessile masses but it is unable to resect muraldisease. Incomplete resection of a sessile polyp may destroy the biopsyspecimen and alter the relationship of the gross specimen given to thepathologist thereby resulting in the pathologist possibly providingincorrect or incomplete study results. The endoscopist is also unable tocorrect uncommon but life threatening procedural complications such asperforations.

Surgical approaches for resectioning diseased tissue are largelypracticed by making large laparotomy incisions or using minimallyinvasive techniques such as laparoscopic surgery in which tissues areresected and repaired through small incisions.

There are numerous surgical devices enabling surgeons to resect diseasedtissue and subsequently anastomosize remaining tissue either through aconventional incision or using a laparoscope and making one or morerelatively small incisions. Additionally, endoscopically assistedstapling devices are known which enable surgeons to remotely anastomoselumenal structures such as the bowel. Endoscopically assisted bowelanastomosis nevertheless typically requires extra-lumenal assistance viaa traditional laparotomy incision or use of a laparoscope.

Trends in surgery are towards minimally invasive procedures as evidencedby developments including laparoscopic cholecystectomy, laparoscopicappendectomy and laparoscopically assisted partial colectomies andhernia repairs. All of these minimally invasive procedures involveintroducing a laparoscope through the abdominal wall and creating otherassociated openings to gain access to the peritoneal cavity in order toperform the necessary surgical procedure. Typically, general anesthesiais required. Endoscopically possible procedures include polypectomy,mucosectomy, and cauterization.

Disadvantages of the laparoscopic method include the need to traversethe abdominal wall, increased operating time secondary to the lack ofexposure for the procedure and possibly the need to convert to an “open”laparotomy in the course of performing the procedure.

Present stapling techniques in surgery are for the most partfunctionally adequate but limited. Devices exist including the GIA andEEA staplers which can be used to transect tissue in a linear andcircular fashions respectively with subsequent anastomosis with staples.The linear GIA is relatively versatile. The EEA is primarily suited forlower colonic circular anastomosis after a lesion has been surgicallyremoved (via laparotomy or laparoscopically) or during a colostomytake-down procedure.

The rigid post of the EFA stapler severely limits its use as well asrequiring that an open procedure be utilized. The steerable endoscopicstapler is useful in allowing for more bowel accessibility; however, itremains dependent upon trans-abdominal surgical exposure prior toutilization.

While laparoscopic surgical instruments have been used for bowelanastomosis, in such procedures the bowel is anastomosizedextracorporially or in an augmented stapled side-to-side fashion.

Possibly relevant to the patentability of this invention are U.S. Pat.Nos. 5,156,614; 5,170,925; 5,172,845; 5,180,092; 5,188,274; 5,188,638;5,197,648; 5,197,649; 5,217,472; 5,219,111; 5,220,928; 5,221,036; and5,242,457.

Non-patent prior art possibly relevant to the patentability of thisinvention includes the article “An Endoscopic Stapling Device: TheDevelopment of a New Flexible Endoscopically Controlled Device forPlacing Multiple Transmural Staples in Gastrointestinal Tissue”appearing at pages 338 and 339 of Gastrointestinal Endoscopy, vol. 35,no. 4, published in 1989, and the article “An Endoscopic Sewing Machine”appearing at pages 36 through 38 of Gastrointestinal Endoscopy, vol. 32,no. 1, published in 1986.

OBJECTS OF THE INVENTION

An object of this invention is to provide methods and apparatus forperforming transmural surgical procedures endolumenally withoutrequiring incisions in the skin.

It is another object of this invention to provide methods and apparatusfor endolumenal surgery resulting in decreased morbidity and mortalityrelating to or resulting from general anesthesia and further providingdecreased post-operative recovery time secondarily to the lack of a bodysurface incision.

It is another object of this invention to provide methods and apparatusfor improved treatment of lesions such as bowel tumors, providing theopportunity to diagnose, resect and cure patients without the need forsubsequent open laparotomy or laparoscopic surgery.

It is another object of this invention to provide apparatus forendolumenal surgery where the apparatus is a coaxial unitary assembly.

It is another object of this invention to provide such apparatus whichis flexible in order to reach any portion of the bowel or any otherlumen into which the apparatus is inserted.

SUMMARY OF THE INVENTION

This invention facilitates preferably endoscopically or radiologicallyassisted, preferably visually guided endolumenal surgery to resectdiseased tissue in a full transmural fashion. Once the resection hasoccurred, the invention facilitates anastomization of clean margins ineither an end-to-end anastomosis or a simple enterotomy closure. Theinvention is not limited to any particular or specific direction,orientation or shape of the incision or performance of such incision inthe course of resectioning; both radial and longitudinal incising arewithin the purview of the invention.

The apparatus and methods of the invention for endolumenal surgery maybe used to perform multiple surgeries including but not limited tofull-thickness transmural polypectomies, resections of submucosallesions, bowel resections, resections of processes such as ulcers thathave violated mucosa and deeper structures, and to control bleeding. Theapparatus and methods may also be used to close perforations viatransmural stapling. Many other endolumenal procedures may also beperformed utilizing the invention including prophylactic or therapeuticappendectomies, resection of bleeding diverticuli or a Meckel'sdiverticulum, anchoring tubes or time-released medications, performinggastroplasty, fallopian tubal ligation, solid organ biopsies, bowelstricturing or partial lung resectioning.

As a result of the flexible nature of the apparatus and methods of theinvention, an operator with either endoscopic or diagnostic imagingguidance can use the apparatus to perform transmural surgery withresection and subsequent anastomosis non-invasively. The invention isnot limited to use with endoscopic or a particular type of diagnosticimaging guidance; magnetic resonance imaging (MRI), CAT scans (CT),fluoroscopic imaging and ultra-sonic imaging guidance may all be used inconnection with the apparatus of the invention and in connection withpractice of the methods of the invention.

With the invention, decreased invasiveness lowers morbidity for thepatient and allows for faster recovery with less time as a patient inthe hospital. Laparoscopy coupled with endolumenal surgery greatlyfacilitates performance of additional surgical procedures and tissuebiopsy.

In one of its aspects this invention provides apparatus forendolumenally resectioning a diseased portion of lumenal tissue in amanner that remaining lumenal tissues are anastomsed with fasteningmeans. In such aspect the apparatus includes means for grippinghistologically normal lumenal tissue, preferably at axially separatedpositions on respective sides of the diseased tissue of interest, andpulling the gripped tissue via mechanical compression with traction orvia suction, i.e. negative pressure with traction, into a cutting zoneremoved from an undisturbed portion of the lumenal tissue. Since thediseased or other undesirable tissue of interest is surrounded by thegripped histologically normal tissue, the diseased or other undesirabletissue of interest is pulled into and preferably across the cuttingzone.

The apparatus further preferably includes means for detaching thediseased lumenal tissue from surrounding healthy lumenal tissue andfurther fastening tissue together so that healthy lumenal tissue isfastened about and across an aperture in the lumenal wall, whichaperture would otherwise be created by detachment of the diseased orotherwise undesirable lumenal tissue from the healthy lumenal tissue, ina manner to close the aperture. The tissue fastening and detaching meanspreferably operates to fasten the healthy tissue together before cuttingthe diseased or otherwise undesirable tissue therefrom in a mannerminimizing chances for diseased tissue subsequently contacting healthytissue and further minimizing likelihood of any aperture remaining forleakage of material through the tissue wall from which the diseased orundesired tissue was removed.

The tissue fastening means portion of the apparatus preferably mayfurther include a plurality of suturing staples and anvils for thefastening, bending or closing of individual suturing staples seriallythere against.

Preferably in one embodiment of the apparatus aspect of the inventionthe cutting means portion of the apparatus includes a longitudinallyelongated blade which preferably translates along a longitudinal axisrespecting the remainder of the apparatus and respecting a lumen intowhich the apparatus has been inserted.

In the stapling and cutting aspect of the invention, the invention isnot limited to a single length stapling and cutting operation. Thestapling and cutting operation may be along only a limited portion ofthe stapling and cutting path so that if the objective of the surgery isremoval of a polyp or perhaps the appendix, where the tissues to beremoved are relatively small and/or encountered in a head-onorientation, the operating physician or other attending healthprofessional may adjust and control the length of the path over whichtissue stapling and cutting is performed.

The invention is not limited to combining tissue stapling and tissuecutting aspects together. The tissue stapling aspect of the inventionmay be practiced without the tissue cutting aspect of the invention andthe apparatus may be configured to provide only tissue stapling or othertypes of tissue suturing or fastening, without tissue cutting beingpresent. This facilitates use of the invention in surgical procedureswhere tissue fastening is required without or only ancillary to tissuecutting.

Further preferably in one embodiment of invention the fastening meansportion of the apparatus includes means for advancing staples preferablyserially against anvils.

In one of the apparatus aspects of the invention, there is provided apreferably longitudinally elongated operating capsule including an outershell preferably having a curved end at one longitudinal extremitythereof with the outer shell preferably including an upper shell portionand a lower shell portion. Hinge means preferably connect the upper andlower shell portions and are generally longitudinally aligned andpositioned along a longitudinally elongated portion of the shell tofacilitate separation of the shell portions and opening of the shell byrelative rotation of the shell portions about the hinge means. When theshell portions are closed, respective facing lip portions may be spacedone from another. The lip portions preferably define a tissue staplingand cutting path and preferably extend around a portion of the curvedend of the shell and along the longitudinally elongated portion of thecapsule, allowing for both radial and longitudinal resections.

The capsule preferably further includes anvil means preferably residentin at least one of the facing lip portions extending along the curvedand longitudinally elongated parts thereof. Suturing staple meanspreferably are resident in the remaining lip portion and preferablyextend along the curved and longitudinally elongated lip parts facingthe anvil means. The suturing staple means pass through any tissuepositioned between the respective lips (and hence positioned between thesuturing staple means and the anvil means), with the preferablyindividual suturing staple means curling back, respecting the directionof suture staple initial movement, into tissue positioned between therespective lips of the upper and lower shell portions. The suturingstaple means preferably curl away from the anvil means due to contacttherewith, thereby securing the tissue together along a line between thesuturing staple means and the anvil means.

The operating capsule further preferably includes gradational tissuesuturing staple advancement and tissue cutting means movable along thelip portion having the suturing staples resident therewithin. Thegradational suturing staple advancement and tissue cutting meanspreferably sequentially advances the staples serially against the anvilmeans in the opposing lip via a preferably transversely flexible rampassembly when the capsule is closed and the shell portions are closetogether, thereby effectuating suturing staple securement of tissuebetween one shell lip housing the suturing staple means and a secondshell lip housing the anvil means. The suturing staple advancement andtissue cutting means is characterized as “gradational” to denote thefeature whereby tissue stapling and cutting may be performed along anyselected length of tissue; there is no need to cut along the entirelength of permissible travel of the suturing staple advancement andtissue cutting means.

The operating capsule further preferably includes a transition portionat one end of the shell, adjoining the upper and lower shell portions,for connecting the operating capsule to a preferably flexible tubularmember carrying cable or other means for controlling operation of thecapsule.

In another of its aspects the capsule preferably further includes meansfor opening the shell preferably by effectuating relative rotation ofthe shell upper portion with respect to the shell lower portion, whichmeans preferably includes a threaded shaft rotatably mounted within thetransition portion of the operating capsule and a carrier threadedlyengaging the shaft and movable axially therealong responsively to shaftrotation. The carrier is preferably pivotally connected to one of theshell portions for pivotally moving the shell portions about the hingesupon movement of the carrier axially along the shaft.

The preferably intralumenal operation of the capsule facilitates passageof a conventional endoscope through the operating capsule in a mannerthat the endoscope may be considered to “snake” or “telescope” into andout of the capsule, moving preferably essentially coaxially with thecapsule and the tubular connection member via which the capsulecommunicates with the operating control module. The endoscope allows theoperator visually to guide the operating capsule up the lumen, with theendoscope preferably protruding from the end of the capsule via anaperture remote from the operating control module to provide excellentvision for the operator.

Once the operator, using the endoscope and the view afforded thereby,has guided the capsule up the lumen to the desired position, theendoscope may be withdrawn into the capsule to permit the operator toobserve the tissue grasping, stapling and cutting operation performed bythe operating capsule from within the capsule. After the diseased orotherwise undesirable tissue is cut and separated from surroundinghealthy tissue, the capsule may be opened thereby permittingthe-operator to observe the wound and the stapling closure thereof withthe endoscope and further to cauterize any bleeding blood vessels asneeded. Even if there is no bleeding, the operating capsule may still beopened to allow inspection of the wound site using the endoscope inorder that the operator may be sure there are no apertures or othersites where leakage could take place through healthy lumen wall tissue.Alternatively, the endoscope may be advanced axially out of the capsule,further up the lumen from the capsule, to observe the wound and thestapling closure thereof from outside the capsule.

In another of its aspects, the apparatus of the invention provides aflexible tubular member adapted for connecting an operating capsule toan operator control module where the flexible tubular member preferablyincludes an outer cylindrical sheath, an inner hollow cylindrical sheathconcentric with the outer sheath and a plurality of preferably conicaldisks between the inner and outer sheaths. Desirably each disk has ahollow central preferably conical portion and an axial aperturepreferably at the disk center, with the inner sheath residing within theaperture. Each disk further preferably includes an annular flangepreferably at the base of the conical portion of the disk. A convexconical exterior surface of the conical portion of each disk preferablyextends through the annular flange and preferably fits into the hollowcentral conical portion of an adjacent disk; this permits the disks tobe in sliding complemental contact with each other. Each flange of eachdisk preferably has a plurality of slots extending radially inwardlyfrom the flange periphery to accommodate control cables which extendthrough the flexible tubular member over the entire longitudinal lengththereof.

In yet another of its aspects, the apparatus of the invention preferablyincludes an operator control module which preferably includes triggermeans for pulling on a first cable and thereby drawing suturing stapleadvancing and tissue cutting means along a lip portion of the operatingcapsule shell having the suturing staples resident therewithin. Thetrigger means thereby serves to advance the staples preferably seriallyagainst anvil means in the opposing lip portion when the shell portionsare closed and effectuates suturing staple securement of tissuepositioned between the lip housing the suturing staple means and the liphousing the anvil means. The operating control module may furtherinclude helical spring means for biasing the trigger against movement ina direction to pull on the first cable.

The control module may further include a pair of pulleys mounted onshafts for unitary rotation therewith. In the apparatus aspect of theinvention, a first cable preferably has its first end wrapped around apulley within the control module rotated by the trigger, with a secondend of the first cable connecting to the staple advancement and tissuecutting means in the operating capsule by travel through the cablecarrying flexible tubular member. A second cable preferably wraps arounda pulley within the control module associated with the knob means formoving the capsule left and right, extends from respective sides of suchpulley through the cable carrying flexible tubular connection means andconnects with a bulkhead portion of the capsule at respective positionswhich are left and right of the capsule vertical axis.

A third cable preferably wraps about another pulley within the controlmodule which is associated with a knob for moving the capsule up anddown, with the third cable extending from respective sides of suchpulley through the flexible connection means and connecting with abulkhead portion of the capsule at respective positions above and belowa capsule horizontal axis.

A fourth cable preferably endlessly wraps around a pulley within thecontrol module which is associated with the knob for opening and closingthe capsule. The fourth cable preferably extends from respective sidesof the pulley through the flexible connection means and connects with apulley within the transition portion. The pulley within the transitionportion preferably threadedly engages a stationary shaft extendinggenerally perpendicularly to a plane defined by juncture of said upperand lower portions. The pulley within the transition portion preferablytraverses the shaft due to relative rotation therebetween and isconnected to the shell upper portion, to open and close the shell upperportion relative to the shell lower portion as the pulley movesrespectively up and down the shaft due to rotation of the knob portionof the operator control module, for opening and closing the capsule.

In yet another apparatus aspect this invention provides apparatus forendoluminally removing a cylindrical wall section of undesired lumenaltissue and circumferentially securing remaining lumenal wall tissue fromeither side thereof annularly about the site of said cylindrical wallsection removal. In this aspect the apparatus preferably includes meansfor fastening together circular margins of lumenal tissue which areadjacent to the undesired lumenal tissue which will be removed as asection of cylindrical lumenal tissue, to prevent creation of acylindrical breach in the lumen which would otherwise result uponremoval of the undesired lumenal tissue as a cylindrical section.

In this apparatus aspect the invention preferably yet further includesmeans for cutting the undesired lumenal tissue, as a cylindrical sectionfrom the lumen, radially inboard of the fastened together circularmargins of the lumenal tissue. Preferably in this apparatus aspect ofthe invention the tissue fastening and cutting means fastens the tissuesimultaneously around the entire 360° of the circular tissue margin. Inthis apparatus aspect of the invention the tissue fastening and cuttingmeans preferably also cuts the tissue simultaneously around the entire360° of the circular tissue margin. Further respecting this apparatusaspect of the invention, the tissue fastening and cutting means ispreferably means for sequentially fastening and then cutting the tissue.In yet another aspect this embodiment of apparatus of the inventionincludes means for stapling tissue together as at least a part of thetissue fastening means.

In yet another aspect this invention provides apparatus for performingendolumenal tubular cylindrical resection where the apparatus includes acontinuous annular lip. Suturing means are preferably present in the lipfor passing through tissue positioned around the lip and therebysecuring the tissue together. In this aspect of the apparatus of theinvention the suture advancement and tissue cutting means is preferablymoveable at the annular lip, for advancing the suturing means throughthe tissue thereby effectuating suturing securment of tissuesimultaneously entirely around the annular lip and cutting the tissueinboard of the sutured securement simultaneously entirely around theannular lip.

In yet another aspect this invention provides methods for endolumenalfull thickness resectioning of tissue by anastomizing the tissue withartificial fastening means.

One preferred practice of one of the method aspects of the inventionincludes inserting a tissue cutting instrument into a body lumen througha naturally occurring body orifice or a surgically created rent. Asecond step in the method is to advance the instrument within the lumento an area of diseased tissue or tissues desired to be resected, wheresurgery is to be performed to remove the diseased tissue or to ligate alumen. Yet another step of the method is to suture surrounding tissuedefining a wall of the lumen to close an orifice therein which wouldotherwise result from removal of undesirable tissue urged or drawn ormanipulated into position for cutting. Yet another step of the method isthe cutting of the diseased urged or drawn or manipulated tissue fromsurrounding tissue defining a wall of the lumen in which the instrumentresides.

An optional step is that of alternately urging or drawing ormanipulating the tissue to be resected into an inner cavity of theinstrument.

Another optional step is that of retaining the cut tissue, which hasbeen urged or drawn or manipulated into the inner cavity of theinstrument, in a position spaced or separated from the lumen wall. Yetanother step is that of withdrawing the instrument along the lumen andfrom the body orifice while retaining the cut tissue, which had beenurged or drawn or manipulated within the inner cavity of the instrument,in position spaced or separated from the lumen wall.

In still another aspect this invention provides a method forendolumenally cylindrically resectioning lumenal tissue where the methodincludes inserting a tissue and suturing cutting instrument into a bodylumen through a naturally ocurring body orafice. A second step in themethod is to advance the instrument within the lumen to an area ofundesired lumenal tissue to be cylindrically resectioned. A third stepof the method is to draw the undesired lumenal tissue to becylindrically resectioned into an annular cutting zone associated withthe instrument. A fourth step in the method is that of stapling thesurrounding lumenal tissue about annular margins of the cylindricaltissue to be resectioned to close an orifice which would otherwiseresult from removal of the undesired lumenal tissue as a cylindricalsection of tissue. A fifth step in the method is that of cutting theundesired cylindrical lumenal tissue from surrounding lumenal tissue.

An optional step in the method is that of retaining the cut undesiredcylindrical lumenal tissue within the instrument while withdrawing theinstrument from the lumen through the naturally occurring orifice tomaintain the cut undesired cylindrical lumenal tissue separated fromhealthy lumenal wall tissue.

In practice of this method aspect of the invention tissue stapling ispreferably performed simultaneously around the entire 360° of the tissuecircular margin. Similarly, the tissue cutting step is preferablyperformed simultaneously around the entire 360° of the circular tissuemargin.

An important aspect of the methods and the embodiments of apparatus ofthe invention is that suturing the tissues surrounding diseased tissue,where the surrounding tissue defines a wall of the lumen, may beperformed prior to cutting diseased or undesired tissue from surroundingtissue defining a wall of the lumen in which the apparatus of theinvention resides.

An important optional aspect of the methods and apparatus of theinvention is retention of the cut and removed tissue within theapparatus interior, away from the lumen wall. This is important in thatit minimizes chances for contact of the severed diseased or otherwiseundesired tissue with the healthy tissue remaining as a part of thebody.

Another important aspect of the methods and apparatus of the inventionis that whereby when malignant, diseased or otherwise undesirable tissueis to be removed from the lumen wall, the entire wall structure throughits entire thickness is cut and removed; no layers of tissue areexcluded or left in place. Further, the methods and apparatus of theinvention facilitate complete removal of the wall tissue by reducing andeffectively minimizing the opportunity for any diseased tissue to remainafter resectioning has been completed.

The methods and apparatus are also applicable to procedures for healthy,normal tissue such as resectioning the Fallopian tubes forsterilization.

The invention also has applicability to performing appendectomies. Insuch case, the operator may use a balloon and a conventional endoscopetogether with apparatus of the invention to draw the appendix into thebowel interior and into an operating capsule portion of the apparatus ofthe invention without completely inverting the appendix. The appendix isdesirably only partially inverted; however, complete inversion is alsoacceptable. Once the appendix has been sufficiently drawn into theoperating capsule, the suturing and tissue cutting operation isperformed at the base of the appendix with the appendix being retainedwithin the operating capsule. This procedure is particularly desirableand indicated when an appendicolith has been detected.

The methods and apparatus, while directed principally to surgery of thegastrointestinal system, are also applicable to surgery for other organsystems including the genital-urinary tracts. The apparatus may also beused and the methods may be modified for use through small skinincisions so as to perform biopsies and to resect tissues remotely usingendoscopic, radiological or other types of imaging as set forth above,within a body cavity such as the thoracic cavity or the abdominalcavity. Further, endovascular surgery may be performed using theapparatus and the methods of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1, which is divided into FIGS. 1A and 1B, is an isometric view of afirst and preferred embodiment of apparatus for removing malignant orother undesirable tissue from the wall of a lumen (such as the colon),while within the lumen (such as the colon), manifesting aspects of theinvention.

FIG. 1A isometrically illustrates an operating control module portion ofsuch apparatus embodying aspects of the invention and a part of cablecarrying flexible tubular apparatus also manifesting aspects of theinvention.

FIG. 1B isometrically illustrates a longitudinally elongated operatingcapsule apparatus manifesting aspects of the invention and the portionof the cable carrying flexible tubular apparatus not shown in FIG. 1A.

FIG. 2 is a side view of the apparatus illustrated in FIG. 1 with aconventional endoscope illustrated in position within the apparatusshown in FIG. 1, illustrating the manner in which an endoscope is usedin conjunction with a preferred embodiment of apparatus manifestingaspects of the invention to remove malignant, other diseased orotherwise undesirable tissue from a lumen wall while within the lumen.

FIG. 3 is an enlarged broken view of a portion of the cable carryingflexible tubular apparatus manifesting aspects of the invention, takenas indicated by the box labeled “FIG. 3” in FIG. 2.

FIG. 4 is a sectional view of the cable carrying flexible tubularapparatus taken at lines and arrows 4-4 in FIG. 2.

FIG. 5 is a sectional view of the cable carrying flexible tubularapparatus taken at lines and arrows 5-5 in FIG. 4.

FIG. 6 is a side view of two conical disks, showing the disks in spacedrelation, which reside within the cable carrying flexible tubularapparatus illustrated in FIGS. 1A, 1B, 2, 3, 4 and 5.

FIG. 7 is a broken, partially sectioned view of operating control moduleapparatus manifesting aspects of the invention taken at lines and arrows7-7 in FIG. 2, illustrating knob and cable movement to effectuatelateral movement of the operating capsule apparatus relative to thelongitudinal axis of the operating capsule.

FIGS. 8 and 9 are top views of operating capsule apparatus illustratingleft and right movement of the operating capsule relative to thelongitudinal axis of the operating capsule.

FIG. 10 is a sectional view of operating control module apparatus takenat lines and arrows 7-7 in FIG. 2, illustrating knob and cable movementto effectuate vertical movement of the operating capsule apparatusrelative to the longitudinal axis of the capsule.

FIGS. 11 and 12 are side views of operating capsule apparatusillustrating vertical movement of the operating capsule relative to thelongitudinal axis of the operating capsule.

FIG. 13 is a sectional view of operating control module apparatus takenat lines and arrows 7-7 in FIG. 2, illustrating knob and cable movementto effectuate opening and closing of the operating capsule.

FIG. 14 is a vertical section, taken at lines and arrows 14-14 in FIG.9, of operating capsule apparatus manifesting aspects of the inventionwith the operating capsule illustrated in its closed position.

FIG. 15 is partially sectioned side view of the operating capsuleapparatus manifesting aspects of the invention with the operatingcapsule illustrated in an open position.

FIG. 16 is a partially sectioned broken view, taken looking from left toright in FIGS. 10 and 13, of operating control module apparatusmanifesting aspects of the invention.

FIG. 17 is a view similar to FIG. 16 but showing certain parts of theoperating control module in different positions.

FIG. 18 is an isometric partially broken view of the operating capsuleapparatus manifesting aspects of the invention with the capsule shownopen to reveal parts of the tissue stapling and cutting apparatus.

FIG. 19 is an isometric view of a lip portion of a lower shell of theoperating capsule apparatus manifesting aspects of the invention and asshown in FIG. 18, further revealing parts of the tissue stapling andcutting apparatus.

FIG. 20 is a side elevation of a suture support member manifestingaspects of the invention.

FIG. 21 is a top view of the suture support member illustrated in FIG.20.

FIG. 22 is a front view of the suture support member illustrated inFIGS. 20 and 21, taken looking from left to right in FIG. 20.

FIG. 23 is an isometric view of the suture support member illustrated inFIGS. 20, 21 and 22, showing the suture support member in place withinthe lower lip of the operating capsule.

FIG. 24 is a partially broken side elevation of the interior of a partof the lower lip portion of the operating capsule apparatus illustratedin FIG. 19.

FIG. 25 is a sectional view of the lower lip of the operating capsuleillustrated in FIGS. 18, 19 and 24, taken at lines and arrows 25-25 inFIG. 24.

FIG. 26 is a sectional view of the lower lip of the operating capsuleillustrated in FIGS. 18, 19 and 24, taken at lines and arrows 26-26 inFIG. 24.

FIG. 27 is a partially broken side elevation of operating controlapparatus manifesting aspects of the invention, taken from the same sideas FIGS. 16 and 17.

FIG. 28 is a side view of operating capsule apparatus manifestingaspects of the invention with the capsule shown open and with remotelyactuable tissue grabbers illustrated within the operating capsule.

FIG. 29 is a partially broken isometric view of operating control moduleapparatus manifesting aspects of the invention illustrating control ofcertain portions of the operating capsule using control knobs of theoperating control module.

FIG. 30 is an isometric partially broken view of the operating capsuleapparatus illustrated in FIGS. 1B, 2, 8, 9, 11, 12, 14, 15, 18 and 28,illustrating the tissue grabbers and control cables used to effectuatevarious motions and functions of the operating capsule.

FIG. 31 is a partially broken isometric view of the operating capsuleillustrated in FIGS. 1B, 2, 8, 9, 11, 12, 14, 15, 18, 28 and 30, showinggrasp of malignant, diseased or otherwise undesired tissue to bring thattissue into the operating capsule interior and schematicallyillustrating tissue stapling and tissue cutting to resect the tissuewithin the operating capsule from surrounding healthy tissue.

FIG. 32 is a schematic side elevation in section of a second embodimentof apparatus for removing malignant or other undesirable tissue from thewall of a lumen (such as the colon), while within the lumen (such as thecolon), by removing a cylindrical segment of the lumenal wall whichincludes such malignant or other undesirable tissue, manifesting aspectsof the invention.

In the drawings and in the following text reference numerals used in thedrawings identify correspondingly numbered structure described in thetext.

DESCRIPTION OF THE PREFERRED EMBODIMENTS AND BEST MODE KNOWN FORPRACTICING THE INVENTION

Referring to the drawings in general and to FIGS. 1A and 1B inparticular, apparatus for removing malignant, other diseased orotherwise undesirable tissue from a lumen wall, such as the colon wall,while within a lumen, such as the colon, is designated generally 10 andincludes a longitudinally elongated operating capsule designatedgenerally 12, an operating control module designated generally 14 and acable carrying flexible tubular member, designated generally 16,connecting operating capsule 12 and operator control module 14.Operating capsule 12 preferably includes an outer shell 18 having apreferably curved end 20 at one longitudinal extremity thereof which isalso a longitudinal extremity of apparatus 10.

FIG. 2 illustrates the manner in which a preferred embodiment of theapparatus from removing malignant, other diseased or otherwiseundesirable tissue from a lumen wall, which apparatus is designatedgenerally 10 and is illustrated in FIGS. 1A and 1B, is preferably usedin conjunction with an endoscope where the endoscope is designatedgenerally 216 and has a tip extremity 218 at the end of a flexibletubular transmission means 220 which fits within and passes through apassageway extending axially the length of the longitudinally elongatedoperating capsule 12 and the cable carrying flexible tubular member 16of apparatus 10.

Endoscope 216 further includes a control segment designated generally222 which is generally conical in configuration, as illustrated in FIG.2. Control segment 222 includes an eyepiece 224, an input light source226, a motion control disk 228, a motion control knob 230, an accessport 232 and a push button control 234.

Tip extremity 218 of flexible tubular transmission means 220 ofendoscope 216 includes a light provided by fiberoptics extending throughflexible tubular transmission means 220 and receiving light from inputlight source 226. Tip extremity 218 of flexible tubular transmissionmeans 220 is maneuverable by the physician or other attending healthcare professional by rotation of motion control disk 228 and motioncontrol knob 230 and by axial advancement of endoscope 216 andparticularly flexible tubular transmission means 220 thereof. Motioncontrol disk 228 has curved edge cut-out portions removed therefrom tofacilitate gripping of disk 228 by the fingers.

A physician or other attending health care professional can inspectionthe colon by inserting tip extremity 218 into the colon through therectum and thereafter guiding tip extremity 218 up the colon, asflexible tubular transmission means 220 is further inserted into thecolon, by watching through eyepiece 224. Fiberoptics connect eyepiece224 with tip extremity 218 thereby providing the physician or otherattending health care professional with a view ahead as flexible tubulartransmission means 220 of endoscope 216 is advanced along the tortouspath defined by the colon. Optionally, the endoscope may have theviewing fiberoptics connected to a television camera, instead of or inaddition to eyepiece 224, thereby permitting the physician or otherattending health care professional to view the interior of the colon (asseen from tip extremity 218) on a high resolution television screen.

Endoscope 216 may further optionally be equipped with small heaters attip extremity 218 to perform cauterizing functions as desired.Additionally, the physician or other attending health care professionalcan utilize access port 232 to insert a catheter or other flexible probeto pass through the length of flexible tubular transmission means 220and out of tip extremity 218, to perform desired surgical orpathological procedures.

Further referring to FIGS. 4 and 5, flexible tubular transmission means220 of endoscope 216 is illustrated in transverse or axial section inFIG. 4. Endoscope 216 has four axial passageways within and extendingthrough flexible tubular transmission means 220; the passageways havebeen numbered 236 with subscripts 1 through 4 identifying respectiveones of the four passageways. Typically, one passageway 236 carries afiberoptic strand providing light at tip extremity 218, a secondpassageway 236 would carry a fiberoptic strand for transmitting theimage seen at tip 218 to eyepiece 224 and/or a suitable televisiondisplay device, a third passageway 236 carries control cables or othercontrol mechanisms actuated by motion control disk 228 and motioncontrol knob 230 while a fourth passageway 236 may be empty, permittingthe physician or other attending health care professional to use avariety of devices insertable into such fourth passageway via accessport 232. The fiberoptics, control mechanisms and the light transmissionmeans resident within passageways 236 have not been illustrated in thedrawings to avoid drawing clutter.

Flexible tubular transmission means 220 is preferably a flexible foamlike or other material, other than for the presence of passageways 236is solid and is surrounded by a flexible rubber, vinyl or other flexiblesmooth material sheath so that flexible tubular transmission means 220may be inserted into the colon via the rectum without damage to rectaltissues.

Flexible tubular transmission means 220 when in place within apparatus10 is preferably but not necessarily coaxial and concentric with cablecarrying flexible tubular member 16, as generally illustrated in FIGS. 4and 5.

Referring still to FIG. 2 and additionally to FIGS. 8, 9, 11, 12, 14,15, 18, 28 and 30, outer shell 18 of operating capsule 12 includes anupper shell portion 22 and a lower shell portion 24 which are connectedby hinges or other suitable hinging means, which are not visible in FIG.1 but are shown schematically in FIG. 15 and are there designatedgenerally 44.

Upper and lower shell portions 22, 24 are longitudinally aligned andmovable relative to one another about hinges 44 or other hinging meansso that upper and lower shell portions 22, 24 can move, thereby to openshell 18, by relative rotation of upper and lower shell portions 22, 24about hinges 44.

Upper and lower shell portions 22, 24 have respective lip portions 26,28 which are preferably spaced from one another when outer shell 18 isclosed and upper and lower shell portions 22, 24 are proximate oneanother, as shown in FIG. 14.

Referring to FIG. 1 and specifically to FIG. 1A and also to FIGS. 7, 10,13, 16, 17, 27 and 29, operator control module 14 includes a base 30, ahandle 32, a housing 34 supported above base 30 by handle 32, a trigger36 and a plurality of control knobs, described in more detail below,facilitating remote operator control of operating capsule 12. Thesecontrol knobs include an outer shell open/close control knob 38, anoperating capsule left/right control knob 40 and an operating capsuleup/down control knob 42, all illustrated in FIG. 1A. Control knobs 38,40 and 42 are mounted on respective shafts, which are largely hidden andhence are not numbered in FIG. 1A, for rotation of respective pulleys toactuate cables wrapped thereabout within housing 34. Various ones ofcontrol knobs 38, 40 and 42 are also illustrated in one or more ofdrawing FIGS. 7, 10, 13, 16, 17, 27 and 29.

Apparatus 10 for removing malignant, other diseased or otherwiseundesirable tissue from a lumen wall, such as the colon wall, whilewithin a lumen such as the colon is designed so that operating capsule12 may be inserted into the colon through the rectum while operatingcontrol module 14 remains outside the patient's body but is connected tooperating capsule 12 remotely by cable carrying flexible tubular member16.

As best shown in FIGS. 16 and 17, operating control module 14 furtherincludes a helically coiling spring steel member 54 which biasespivotally movable trigger 36 against movement in the direction to pullon a first cable 48 which is connected to pulley 52 and wrap aboutpulley 52 upon rotation thereof. First cable 48 extends through cablecarrying flexible tubular member 16 into operating capsule 12 to connectwith a ramp-knife assembly 50, which performs tissue fastening stapleadvancement and tissue cutting. Ramp-knife assembly 50 is desirablyunitary in that the assembly is fabricated from a plastic-metal assemblyor from a single piece of metal or plastic. Ramp-knife assembly 50 isillustrated in FIGS. 17 and 18 and is pulled by cable 48 along a pathdefined by lip portion 28 of lower shell portion 24.

Referring specifically to FIGS. 16 and 17, trigger 36 is connected topulley 52 via a piece of helically coiling spring steel 54 defining ahelical leaf-like spring. When actuating the tissue fastening stapleadvancement and tissue cutting means, specifically ramp-knife assembly50, the operator pulls on trigger 36, pivotally moving trigger 36 abouta pivotal mounting point 37 from the position illustrated in FIG. 16towards the position illustrated in FIG. 17. As the operator pulls ontrigger 36, helical coiling spring steel member 54 extends and a portionof helical coiling spring steel member 54 is pulled from a position ofrest, where it is wrapped about a cylindrical shoulder portion 58 ofpulley 52, thereby rotating pulley 52 in the direction illustrated byarrow A in FIG. 17. This action draws first cable 48 in the directionillustrated by indicator arrow A₁ in FIG. 17.

Drawing first cable 48 in this direction causes the remaining end ofcable 48, which is connected to ramp-knife assembly 50 within operatingcapsule 12 as illustrated in FIG. 24, to pull ramp-knife assembly 50along and within lip portion 28 of lower shell portion 24. If theoperator pulls trigger 36 through the maximum angular range of travelfor trigger 36, from the position illustrated in FIG. 16 completely tothe position illustrated in FIG. 17, ramp-knife assembly 50 moves fromthe position illustrated in FIG. 18, along the entire curved and thenstraight length of lip portion 28, to the position illustrated in FIG.19. Travel of ramp-knife assembly 50 is limited by contact of theleading edge of ramp-knife assembly 50, which leading edge is designated300 in the drawings, with an upstanding portion of lower lip 28, asillustrated in FIG. 19. Hence, once the operator has pulled trigger 36through its maximum angular range of travel, the operator will sense byfinger feel that trigger 36 cannot be further pulled due to the contactof the leading edge of the knife-ramp assembly with upstanding supportmember 300 illustrated in FIG. 19.

It is not necessary that trigger 36 always be moved by the operatorthrough its entire range of angular and linear travel to thereby pullramp-knife assembly along the entire range of travel along lip 28. Thephysician or other attending health professional controlling trigger 36may choose to advance ramp-knife assembly only along the curved portionof lip 28 illustrated in FIGS. 17 and 18. For example, the invention maybe used to remove tissue encountered by the operating capsule in ahead-on fashion, when moving in the direction indicated by arrow B inFIG. 18. Alternatively, if a large mass of tissue is to be removed,where the tissue drawn into operating capsule 12 overlies the entiretyof lip portion 28, the physician or other attending health professionalpulls trigger 36 through its full range of angular motion thereby tostaple and cut tissue along the entire length of lip portion 28.

As illustrated in FIGS. 16, 17, 18 and 30, first cable 48 is preferablyof the type including an inner strand housed within an outer sheathwhere the inner strand is preferably solid. Whether the inner strand issolid or braided, the inner strand is a high tensile strength materialand is moveable axially respecting the outer sheath. The inner strand offirst cable 48 is denoted 48, in the drawings while the outer sheath offirst cable 48 is denoted 480. Inner strand 48, and outer sheath 480have not been separately numbered in all of the drawings to avoidexcessive drawing clutter.

Referring to FIGS. 3, 4, 5 and 6, cable carrying flexible tubular member16, through which first cable 48 connects trigger 36 with ramp-knifeassembly 50, includes an outer preferably cylindrical sheath 60, ahollow inner preferably cylindrical sheath 62, which is preferably butnot necessarily concentric with outer sheath 60, and a plurality ofpreferably truncated or frusto-conical disks between outer sheath 60 andinner sheath 62. The individual conical disks are designated generally64 in the drawings. Disks 64 are best illustrated in FIGS. 3, 4, 5 and6.

Each individual conical disk 64 preferably includes a hollow centralconical portion 66 and an annular flange 68 at the base of conicalportion 66. Each disk 64 has an axial inner aperture 74 preferably atthe center of conical portion 66 of the disk. Inner sheath 62 resideswithin axial inner apertures 74 of disks 64.

Each disk 64 preferably further has a convex conical exterior surface 70formed on central conical portion 66. Each disk 64 also preferablyincludes a preferably concave conical surface 72 formed on the interiorof central conical portion 66 and a preferably convex conical surface 70formed on the exterior of central conical portion 66. Concave conicalinterior surface 72 is shaped for sliding, substantially complementallyfacing contact with convex conical exterior surface 70 of an axiallyimmediately adjacent disk 64. This arrangement, facilitating movable,sliding and twisting contact between axially adjacent disks 64, is bestillustrated in FIGS. 5 and 6.

The generally conical geometry of the portions of disks 64 extendingfrom annular flanges 68 serves to maintain adjacent disks generally incoaxial and aligned position but nevertheless permits the column ofdisks 64 residing within outer cylindrical sheath 60 of flexible member16 to twist and turn, in order to follow what may be a very tortuouspath defined by a body lumen as operating capsule 12 travels axiallywithin that lumen. The arrangement of the concave conical interiorsurface 72, in substantially complementally facing contact with convexconical exterior surface 70 of the immediately adjacent disk, providessufficient rigidity that flexible member 16 cannot be sharply bent. Thisis important in order that flexible member 16 may keep cables, such asfirst cable 48 via which the operator at control module 14 controlsoperating capsule 12, from bending. If those cables bend and developkinks, control over operating capsule 12 may be lost. Loss of controlover operating capsule 12 could be catastrophic, requiring withdrawal ofthe apparatus 10 from the patient prior to completion of the surgicalprocedure of interest.

When cable carrying flexible tubular member 16 is bent to an extreme,interference between flanges 68 of adjacent disks 64 prevents furtherbending of tubular member 16 thereby minimizing the likelihood of anytwisting of the control cables carried by and passing through cablecarrying flexible tubular member 16.

The arrangement of disks 64 prevents self-collapse of cable carryingflexible tubular member 16 and also prevents telescoping of flexibletubular member 16. Disks 64 permit flexible tubular member 16 totransmit axial driving force, which is required to be applied by thephysician or attending health care professional, to move operatingcapsule 12 and cable carrying flexible tubular member 16 axially alongthe colon.

Disks 64 facilitate transmission of that driving force axially eventhough the axis of the colon, and therefore the path being followed byoperating capsule 12 and cable carrying flexible tubular member 16, iscurvilinear. As cable carrying flexible tubular member is used toadvance operating capsule 12 along the axis of the colon, the axisorientation is continuously changing as is the position or positions ofcurvature of flexible tubular member 16 as operating capsule 12 isinserted further and further into the colon. The arrangement of conicaldisks 64 within member 16 provides the requisite ability to axiallytransmit the necessary driving force as flexible tubular member 16changes in position and orientation while advancing along the colonaxis.

Referring to FIGS. 1A, 7, 8 and 9, left and right control of operatingcapsule 12 is effectuated by rotation of capsule left/right control knob40. Capsule left/right control knob 40 is rotatably mounted on a shaft112, which in turn is rotatably mounted in housing 34 of operatingcontrol module 14 and has a pulley 114 fixedly connected thereto asillustrated in FIG. 7. A cable 116, referred to as a “second” cable todistinguish cable 116 from “first” cable 48, is wrapped about pulley114; respective ends of second cable 116 extend from operating controlmodule 14 through cable carrying flexible tubular member 16 to operatingcapsule 12. Rotation of left/right control knob 40 in respectivedirections results in operating capsule 12 moving to the right and tothe left relative to the longitudinal axis thereof as illustratedrespectively in FIGS. 8 and 9. In FIGS. 8 and 9 the referencedlongitudinal axis is denoted by hash marks and movement of operatingcapsule 12 to the right and to the left with respect thereto is denotedby arrows R and L in FIGS. 8 and 9 respectively.

Referring to FIG. 15, operating capsule 12 has an openable portion,defined by upper shell portion 22 and lower shell portion 24, and atransition portion denoted generally 118. Transition portion 118 is notopenable; transition portion 118 serves to reduce the cross-sectionalsize of apparatus 10 from the cross-sectional size of operating capsule12 in the area of upper and lower shell portions 22, 24 down to asmaller cross-sectional area as defined by the cross-section of cablecarrying flexible tubular member 16.

Transition portion 118 includes a bulkhead 120 and an outer skin orshell portion 122 which is generally hollow as illustrated in FIG. 15.

Bulkhead 120 preferably provides a solid support and mounting area forthe mechanism used to move upper shell portion 22 of capsule 12 as uppershell portion 22 is rotated relative to lower shell portion 24 therebyto open operating capsule 12. Additionally, bulkhead 120 providessupport for removable lower lip portion 28. Furthermore, bulkhead 120receives respective ends of second cable 116, specifically respectiveends of inner strand 116 _(I) of second cable 116. These respective endsof second cable 116 are preferably connected to bulkhead 120 at thelateral extremities of bulkhead 120 at a position on the verticalmidpoint of bulkhead 120. Second cables 116 preferably enter transitionportion 118 through respective appropriate slots in a flange 124 locatedat the axially opposite end of transition portion 118 from bulkhead 120.Flange 124 is illustrated in FIG. 30.

Respective outer strands 116, of second cable 116 preferably residewithin respective slots formed in flange 124 on diametrically oppositesides of flange 124, at the horizontal axis thereof. These respectiveends of outer strands 116 _(O) of second cable 116 are illustrated inFIG. 30. The tie-ins of inner strands 116 _(I) to bulkhead 120 have notbeen illustrated in the drawings to avoid drawing clutter.

Respective ends of second cable 116 passing through cable carryingflexible tubular member 16 reside within diametrically opposedrespective slots designated 126, 126′ in annular flanges 68 of disks 64as illustrated in FIG. 4. Second cable 116 enters cable carryingflexible tubular member 16 from housing 34 of control module 14 via aflange 128, illustrated in FIG. 7, which corresponds generally to flange124 located at the opposite end of cable carrying flexible tubularmember 16 and illustrated in FIGS. 17 and 24.

Referring generally to FIGS. 10, 11 and 12, up/down control of operatingcapsule 12 is effectuated generally by rotation of capsule up/downcontrol knob 42 forming a part of operating control module 14. Capsuleup/down control knob 42 is rotatably mounted on a shaft 130 which isrotatably mounted for rotation relative to and within housing 34 ofcontrol module 14. Fixedly connected to shaft 130 is a pulley 132 aboutwhich is wrapped a third cable 134. Similar to first and second cables48, 116, third cable 134 desirably has a solid inner strand denoted withthe subscript “I” and an outer sheath denoted with the subscript “O”.

Respective portions of third cable 134 extend through cable carryingflexible tubular member 16 and into transition portion 118 whererespective ends of third cable 134, specifically respective ends ofinner strand 134 _(I), are fixedly connected to bulkhead 120. Theserespective ends of third cable 134 are fixedly connected to bulkhead 120at the top and bottom extremities of a vertical axis of operatingcapsule 12. These connections are not illustrated in the drawings toavoid drawing clutter.

Similarly to second cable 116 and first cable 48, third cable 134 enterscable carrying flexible tubular member 16 by passing through respectiveapertures in flange 128 and resides within slots 136, 136′ in flanges 68of disks 64, as third cable 134 extends the length of cable carryingflexible tubular member 16. This arrangement of third cable 134 passingthrough apertures in flange 128 is illustrated in FIG. 29. Thearrangement of third cable 134 in slots 136, 136′ in flanges 68 of disks64 is illustrated in FIG. 4. The arrangement of third cable 134 inrespective slots in flange 124, where third cable 134 enters transitionportion 118, is illustrated in FIG. 30.

Rotation of capsule up/down control knob 42 in respective directionsdenoted by respective unnumbered arrows in FIG. 10 results in movementof operating capsule 12 up and down with respect to a longitudinalreference axis, as illustrated by arrows U and D in FIGS. 10 and 11respectively, as cable 134 pulls in respective directions on bulkhead120 due to rotation of pulley 132.

Capsule left/right control knob 40 and its associated pulley shaft andcable have not been numbered in FIG. 10 to avoid drawing clutter.Similarly, operating capsule up/down control knob 42, shaft 130, andpulley 132 and associated third cable 134 have not been illustrated inFIG. 7 to avoid drawing clutter.

Referring to FIG. 13, opening and closing of operating capsule 12 ispreferably effectuated by rotation of capsule open/close control knob 38by the operator. Capsule open/close control knob 38 is mounted on ashaft 138 which is rotatably journaled within and extends into theinterior of housing 34. A bevel gear 140 is fixedly mounted on shaft 138at the end thereof opposite from capsule open/close control knob 38within housing 34.

A pulley 142 is mounted coaxially with pulleys 114 and 132 but is freelyrotatable independently thereof. Pulley 142 has a bevel gear surface 144formed on one side thereof. The teeth of bevel gear surface 144 meshwith the teeth of bevel gear 140. Accordingly, rotation of capsuleopen/close control knob 38 and consequent rotation of bevel gear 140serves to rotatably drive pulley 142 about its axis of rotation. Afourth cable 146 is wrapped about pulley 142 so that upon rotation ofpulley 142, one of the two portions of fourth cable 146 extendingtherefrom is advanced off of pulley 142 while the remaining portion offourth cable 146 is retracted by being wound onto pulley 142.

Fourth cable 146 extends from operating control module 14 through cablecarrying flexible tubular member 16 and into transition portion 118.

Referring to FIGS. 13 and 14, a threaded shaft 148 is preferablyrotatably mounted on a pedestal block 150 which is fixedly connected tobulkhead 120. A drive pulley 152 is fixedly mounted at one end ofthreaded rotatable shaft 148 and is rotatable unitarily therewith.Fourth cable 146 is preferably wrapped about drive pulley 152 asillustrated in FIGS. 13 and 14.

Advancement of one portion of fourth cable 146 and concomitantretraction of the remaining portion of fourth cable 146 due to rotationof pulley 142 responsively to rotation of capsule open/close controlknob 38 causes rotation of threaded rotatable shaft 148.

A nut 154 threadedly engages shaft 148 and is movable freely therealongin response to rotation of shaft 148. Fixedly connected to nut 154 is anarm 156. Arm 156 extends generally horizontally from nut 154, towardsthe side of operating capsule 12 where lip portions 26, 28 are located;this is the side of operating capsule 12 which opens upon rotation ofupper shell portion 22 relative to lower shell portion 24.

A pin 158 preferably extends generally longitudinally parallel with theaxis of operating capsule 12 and cable carrying flexible tubular member16, from arm 156 towards the curved axial and longitudinal extremity ofoperating capsule 12. Pin 158 has a shaft portion and a head portion,neither of which are numbered in the drawings. The head portion of pin158 is mounted in a lift arm 160 connected to upper shell 22 and forminga portion thereof. Pin 158 passes through a slot or other opening inbulkhead 120 to provide the connection between arm 156 and lift arm 160.

As drive pulley 152 rotates threaded shaft 148 in a given direction,since shaft 148 is axially immovable nut 154 rides up or down shaft 148,depending on the direction of rotation of shaft 148. As nut 154 rides upshaft 148 when the apparatus is positioned as illustrated in thedrawings, such rotation of shaft 148 causes upper shell portion 22 torotate upwardly relative to lower shell portion 24 thereby openingoperating capsule 12 as illustrated generally FIG. 18. Rotation ofthreaded shaft 148 in the opposite direction due to advancement of theremaining portion of fourth cable 146, causes nut 154 to ride downwardlyalong threaded rotatable shaft 148, causing upper shell portion 22 torotate towards lower shell portion 24 thereby closing operating capsule12 in response to rotation of capsule open/close control knob 38.

While the operating capsule open/close mechanism has been illustratedutilizing motion of a nut along a threaded shaft to effectuate theopening and closing, it is within the purview of the invention toprovide one or more small electric or hydraulic motors to perform theopening and closing function. When such motors are used, gears orpistons on any other appropriate drive mechanism on means may be used toopen and close the operating capsule.

Referring generally to FIGS. 18, 19, 24 and 26, ramp-knife assembly 50is fabricated with a knife portion 76 having an inclined, leading tissuecutting edge 78. Ramp-knife assembly 50 further includes a horizontalbase portion 80 and an inclined staple advancing ramp portion 82. Firstcable 48 is removably affixed to ramp-knife assembly 50, preferably tothe bottom surface of horizontal base portion 80 at a position thereonimmediately underneath inclined leading tissue cutting edge 78 of knifeportion 76, as illustrated in FIGS. 18 and 24 through 26.

First cable 48 is preferably retained in position and removably affixedto ramp-knife assembly 50 by a spring-clip 302 which is affixed to thelower surface of ramp-knife assembly 50 as best illustrated in FIGS. 25and 26. Spring-clip 302 retains an end of first cable 48 in engagementtherewith; first end of cable 48 preferably is equipped with a knob 304,illustrated in FIG. 24, which interacts with spring-clip 302 so thatwhen first cable 48 is advanced in a direction to the right in FIG. 24,interaction between spring-clip 302 and knob 304 forces ramp-knifeassembly 50 to the right in FIG. 24. This arrangement with spring-clip302 holding first cable 48 in place permits reuse of cable 48 and themajor portion of capsule 12 once a suturing or stapling function hasbeen performed and the staples have been used to secure tissue togetherand are no longer resident within lower lip 28 of capsule 12.

Preferably lower shell portion 24 of operating capsule 12 is fabricatedof plastic, metal or some other suitably rigid material so that lowershell portion 24 has a hollow interior. Most preferably, lower shellportion 24 of operating capsule 12 is plastic, as is lip portion 28.This hollow interior, which is visible via the cut-aways in FIGS. 18 and19 and in the sectional views of FIGS. 25 and 26, defines the curved andthen straight path traveled by ramp-knife assembly 50 as ramp-knifeassembly 50 is advanced and performs its staple advancing (for tissuefastening) and tissue cutting functions.

Most preferably lip portion 28 of lower shell 24 is constructed to beeasily snapped into place and removed from the remainder of lower shellportion 24, with lip portion 28 preferably being constructed asillustrated in FIG. 19. Suitable snap-in and snap-out fixtures andgeometry may be provided at respective ends of lip portion 28; one suchsnap-in and snap-out structure is denoted 84 in FIG. 19. The snap-in andsnap-out construction of lip portion 28 is preferred in order that oncestaples have been placed into tissue and a given surgical procedure hasbeen completed, a spent lip portion 28 may be removed from lower shell24 and replaced with a fresh lip portion 28 loaded with suitable staplesin order that operating capsule 12 may be reused numerous times tominimize costs associated with performance of such surgical procedures.

Respecting materials for operating capsule 12, so long as the materialsmay be adequately sterilized for reuse of operating capsule 12, anysuitable plastic, metal or other suitable rigid or semi-rigid materialor materials may be used. Use of plastic is preferred to providecompatibility with MRI.

Lip 28 has a longitudinally extending slot running along the lowerinside portion thereof. Due to the positioning of lip 28 in FIG. 19,that slot cannot be seen in FIG. 19 but is clearly shown in thesectional views of FIG. 26. The slot, which is designated generally byindicator number 186 in FIG. 26, is defined by a lower extremity 188 ofan inner wall 96 of lower lip 28 and a horizontal bottom surface 190 oflower lip 28.

An inner lateral extremity of horizontal base portion 80 of ramp-knifeassembly 50, which supports an upstanding knife support 192 for knifeportion 76 of ramp-knife assembly 50, extends laterally outwardlythrough and from that slot, inwardly into the interior of the capsule.This construction is illustrated in FIGS. 25 and 26.

Additionally, knife support 192, knife portion 76 and specificallyleading knife cutting edge 78, extend above the upper extremity of lipassembly 28; the upper extremity is denoted 86 in FIGS. 19 and 25. Upperextremity 86 is defined by a preferably planar surface 88, bestillustrated in FIG. 23, which may be horizontal or may be slightlyinwardly inclined from the outer portion of lip 28 to the inner portion.

In either case, inclined leading knife cutting edge 78 of knife portion76 extends above the upper inner edge of lip 28 defined by upperextremity 86. Hence, any tissue extending across planar upper surface 88past edge 86 and into the interior of capsule 12 is cut by inclinedleading tissue cutting edge 78 of knife 76 as ramp-knife assembly 50traverses the curved and then straight path defined by the hollowinterior of lower lip 28.

While the apparatus in the preferred embodiment has been illustratedwith the opening between upper and lower lips 26, 28 of capsule 12 beinggenerally at the horizontal mid-point of capsule 12, this is notrequired. The position at which upper lower shell portions 22, 24 ofcapsule 12 separate to provide the two facing lips where the tissuesuturing and cutting function is performed does not have to be at thehorizontal mid-point of capsule 12 and, indeed, does not even have to bea symetrical position of closure respecting the longitudinal axis ofcapsule 12.

The preferred configuration of ramp-knife assembly 50 illustrated inFIGS. 18 and 19 and shown in section in FIGS. 25 and 26 lends stabilityto the assembly. Specifically, working surfaces of ramp-knife assembly50 are desirably at least generally planar; exemplary of these areoutboard surface 90 of suture advancing ramp, the bottom surface oframp-knife assembly 50, namely the downwardly facing surface ofhorizontal portion 80 of ramp-knife assembly 50 which is not numbered inFIGS. 19, 25 or 26, the exterior surfaces of knife support portion 192and outboard (with respect to operating capsule 12 as a whole) surface92 of knife portion 76 of ramp-knife assembly 50. Outboard surface 92preferably rides in complementary facing contact with an inwardly (withrespect to operating capsule 12 considered as a whole) facing surface 94of inner wall portion 96 of lower lip 28, as illustrated in FIG. 19.

Ramp-knife assembly 50 may be fabricated with two separate portions ofoutboard or outwardly facing surface 90, a forward portion 90 _(F) and arearward portion 90 _(R), where surfaces 90 _(F) and 90 _(R) may be atslight angles to one another about a vertical boundary therebetweendenoted 98 in FIG. 19. This geometry may be desirable if thelongitudinal length of ramp-knife assembly 50, denoted L₁ in FIG. 19, isrelatively large with respect to the radius of curvature of the curvedend of lower lip 28 and hence the radius of the resultantly curvedportion of the path along which ramp-knife assembly 50 travels as itperforms is tissue fastening staple advancement and tissue cuttingfunction. That path is preferably defined by the hollow interior oflower lip 28.

In the preferred embodiment of the apparatus of the invention,ramp-knife assembly 50 is preferably fabricated of a single piece offlexible material, preferably plastic, with the material being flexibleenough to permit the ramp-knife assembly to slide easily around thecurved portion of the path along which ramp-knife assembly travels as itperforms its tissue fastening staple advancement and tissue cuttingfunction. Of course, the knife portion is preferably metal to provide anextremely sharp edge so that the tissue cutting results in a clean welldefined cut.

Sliding, substantially complementally facing contact between surfaces 90_(F) and 90 _(R) and the inwardly facing surface 100 of outer wall 102of lower lip 28, as illustrated in FIG. 26, provides further stabilityas ramp-knife assembly travels within lower lip 28.

The tissue fastening staple apparatus aspects of the invention are bestillustrated in FIGS. 18 through 26. Specifically referring to FIG. 20,individual staples 104 are preferably formed of extremely fine solidstainless steel wire, titanium wire or other suitable permanent ordissolvable tissue fastening stapling/suturing material. Each staple 104is preferably initially formed of three straight portions, specificallytwo stapling fingers denoted 262 and 262′ connected by a stapling basedesignated 264. Stapling fingers 262, 262′ are preferably initiallyparallel to one another and preferably are of the same length. Staplingfingers 262, 262′ extend from stapling base 264 preferably atsubstantially right angles to stapling base 264. Each staple 104 ispreferably mounted in a respective staple support block of a staplesupport member.

Referring generally to FIGS. 20 through 23, a staple support member isdesignated generally 166 and includes two staple support blocks, whichare designated 168, 168′ respectively, connected integrally together bya generally trapezoidally configured solid adjoining member 170.Preferably, each staple support member 166 is of integral constructionsuch that respective staple support blocks 168, 168′ and adjoiningmember 170 are a unitary piece of preferably injection molded orcompression molded plastic.

As apparent from FIGS. 20 through 23, staple support blocks 168, 168′ ofeach staple support member 166 are preferably of rectangular solidconfiguration and are longitudinally offset one from another, asillustrated. Each staple support block 168, 168′ preferably has alongitudinal groove 172 extending the longitudinal length of the staplesupport block, in an upwardly facing preferably planar surface of thestaple support block 168, 168′. Longitudinal groove 172 is sized and hasa shape respecting stapling base 164 so as to retain stapling base 164in a releasable manner. Once the tissue fastening stapling function hasbeen performed and the operating capsule is to be removed from the body,staples 104 pull easily out of longitudinal grooves 172 and remainwithin the stapled tissue which the staples have penetrated, therebysecuring the stapled tissue together.

While staple support blocks 168 preferably are generally rectangularsolid in configuration, adjoining member 170 preferably has an inclinedlower surface designated generally 174.

A plurality of staple support members 166 are preferably housed withinlower lip 28 of lower shell portion 24; an exemplary group of staplesupport members 166 is illustrated in FIG. 24. Each staple support block168, 168′ of a staple support member 166 is substantially verticallyaligned with a respective preferably rectangular aperture 108 formed inplanar upper surface 88 of lip 28 as illustrated in FIG. 23. Apertures108 are preferably arranged in two parallel rows extending along thecurved and then straight path traveled by ramp-knife assembly 50 as suchpath is defined by lower lip 28. Apertures in the inner row are denotedwith a subscript “I” while apertures 108 in the outer row are, denotedwith the subscript “O”. Spacing of apertures 108 _(I) and 108 _(O) andspecifically the longitudinal offset of apertures 108 _(I) and 108 _(O)corresponds to the longitudinal offset of respective staple supportblocks 168, 168′ of a single staple support member 166, with suchoffsets being best illustrated in the isometric view provided by FIG.23.

Similar nomenclature is used to denote inner and outer staple supportblocks 168 which are in registry with inner and outer apertures 108.Outer staple support blocks, in the outer row and which are aligned withapertures 1080, are denoted 1680. Staple support blocks which are in theinner row and are in registry with apertures 108 _(I) are denoted 168_(I). This arrangement is illustrated in FIG. 23.

Referring specifically to FIG. 24, a section of lip portion 28 fromlower shell portion 24 is depicted with the outer wall 102 substantiallybroken away to reveal the arrangement of staple support members 166 andthe manner in which staple support members 166 are upwardly advanced byramp-knife assembly 50 to effectuate tissue securement by stapling.

In FIG. 24 inner wall 96 of lower lip 28 has a surface 106 which isfacing inwardly respecting the interior of lower lip 28 but facesoutwardly respecting operating capsule 12 taken as a whole.

Surface 106 has a series of vertically extending channels formedtherein, which are adapted for sliding receipt of a staple support block168 of a staple support member 166. Only one of these channels, whichhas been designated 176 in FIG. 24, has been illustrated in FIG. 24, toaid drawing clarity. There is preferably one channel 176 for each staplesupport member 166.

Each channel 176 is defined by a rib 310, one of which has beenillustrated in FIG. 23, extending transversely outwardly from surface106, in a direction perpendicular to the plane of the paper in FIG. 24,and which extends along the entire vertical height of surface 106 inFIG. 24. Respective vertically extending longitudinally facing surfacesof two adjacent ones of these ribs are illustrated in dotted lines inFIG. 24 and are denoted 180; surface 180 of rib 310 appears as a line inFIG. 23.

At the end of each rib remote from surface 106 is a web which isparallel with surface 106. Two such webs have been illustrated in FIG.24 and are designated generally 178; one web 178 is shown in FIG. 23 andhas been broken away to illustrate the relationship between web 178 anda suture support block 168 _(I) and specifically an oppositelylongitudinally facing surface 181 thereof. The two dotted lines whichdenote the longitudinally facing transversely extending surfaces of rib310, which surfaces are hidden by webs 178 in FIG. 24, are denoted 180in FIG. 24. A longitudinally facing surface 180 of a rib 310 islongitudinally spaced from an immediately adjacent rib 310 a distancejust slightly greater than the longitudinal length of a suture supportblock 168, as denoted by dimensional arrow L in FIG. 23. Hence, aninboard suture support block 168 of a suture support member 166 isslidably vertically movable in a groove defined by two adjacent ribs310.

Webs 178 overlie longitudinally facing surfaces 180 of the ribs 310.Ribs 310 extend transversely outwardly respecting surface 96 a distanceslightly greater than the thickness, in the transverse direction, ofsuture support block 168, which thickness is denoted by dimension T inFIG. 23. Since webs 178 overlie longitudinally facing surfaces 180 andsince the ribs are slightly longer than the thickness of a suturesupport block 168, webs 178 serve to retain a suture support block invertically sliding disposition within the groove defined by surface 106,rib 310 and web 178.

A portion of upper surface of lip 28 between inner apertures 108, andouter aperatures 108, defines a stop for suture support members 166 andis designated generally 182 in FIG. 23. This strip of preferably plasticmaterial extends longitudinally and interferes with upper surfaces 184of adjoining members 170 when suture support members 166 are urgedsufficiently far upwardly within grooves defined by adjacent ribs 310.Hence, as ramp-knife assembly 50 urges the suture support members 166vertically upwardly, sutures 104 may protrude through aperatures 108 andupper portions of suture support blocks 168 _(I), 168 _(O) may similarlyprotrude through corresponding aperatures 108 _(I) and 108 _(O).However, interference between adjoining member 170 of suture supportmember 166 and material strip 182 limits upward travel of the suturesupport member 166.

The suturing members have been illustrated as staples 104. While staplessuch as those illustrated as 104 are preferred, any suitable suturingmeans may be utilized in place of the staples illustrated as 104 in thedrawings.

Still referring to FIG. 24, a plurality of outer staple support blocks168 _(O) forming portions of respective staple support members 166 areshown. For drawing clarity, an inner staple support block 168 _(I) hasbeen illustrated in dotted lines for only a single one of the staplesupport members 166. The staple support block 168 _(I) shown in dottedlines is illustrated in position in the groove defined by the ribs 310whose longitudinally facing surfaces are shown in dotted lines as 180.

Prior to contact by the ramp-knife assembly 50, which is illustrated inposition generally to the left in FIG. 24, an individual staple supportmember 166 is positioned as illustrated by the staple support block 1680at the extreme right hand side in FIG. 24. In such position, staplingfingers 262, 262′ are straight and extend at substantially right anglesfrom the upper surface of staple support block 1680.

As first cable 48 is drawn to the right in FIG. 24, first cable 48 pullsramp-knife assembly 50 to the right in FIG. 24. As ramp-knife assembly50 travels to the right in FIG. 24, the inclined ramp 82 is positioneddirectly under area 182 in planar upper surface 88 of lip 28,illustrated in FIGS. 18, 19 and 23, separating apertures 108 _(I) fromapertures 108 _(O). Staple support members 166 are positioned withrespective staple support blocks 168 _(I), 168 _(O) in registry withassociated apertures 108 _(I), 108 _(O) and hence with each adjoiningmember 170 of a staple support member aligned with inclined ramp 82.

Inclined lower surfaces 174 of adjoining members 170 are preferablyinclined at an angle corresponding to that of ramp 82. Hence, asramp-knife assembly 50 is moved to the right in FIG. 24 by first cable48, inclined ramp 82 contacts inclined lower surfaces 174 of adjoiningmembers 170 and urges staple support members 166, of which adjoiningmembers 170 are parts, vertically upwardly. This progressive verticallyupward travel of staple support members 166, due to the horizontaltravel of ramp-knife assembly 50, is illustrated in FIG. 24.

As travel of ramp-knife assembly 50 to the right in FIG. 24 pushesstaple support members 166 vertically upwardly, stapling fingers 262,262′ associated therewith pass through an aperature 108 with whichstaple support block 168 carrying staple 104 is in registry and emergefrom upper surface 88 of lower lip 28. As ramp-knife 50 continuesfurther to the right in FIG. 24, ramp surface 82 continues to urgestaple support members 166 vertically upwardly. Stapling fingers 262,262′ encounter anvil surfaces 260 which are formed in upper lip 26 ofupper shell portion 22 and are illustrated in FIG. 24. As staplingfingers 262, 262′ are urged against anvil surfaces 260, stapling fingers262, 262′ are bent and curve in a plane defined by the slot-likeconfiguration of anvil surfaces 260. The curvature of stapling fingers262, 262′ in a plane defined by ramp-knife assembly 50 is shown bystapling fingers 262, 262′ associated with the staple support block 1680at the extreme left hand side of FIG. 24. The slot-like configuration ofanvil surface 260 in upper lip 26 is illustrated in FIG. 26.

When tissue is present between lip portions 26 and 28 and staplingfingers 262, 262′ of a staple are driven through such tissue and againstanvil surfaces 260, the resulting curvature of stapling fingers 262,262′ illustrated in FIG. 24 after passage through the tissue locatedbetween lip portions 26 and 28 secures that tissue together. Due to theprovision of outer and inner staple support blocks 168 _(O), 168 _(I) inregistry with respective aperatures 108 _(O) and 108 _(I), two parallellines of staples or sutures securing together tissue results. Theresulting securement of the tissue is illustrated by the dotted lines inFIG. 31.

Further respecting anvil surfaces 260, as illustrated in section in FIG.26, anvil surfaces 260 are offset one from another with the curveddownwardly facing portions of anvil surfaces 260 in upper lip 26 causingthe resulting curve of stapling fingers 262, 262′ in a direction backtowards the direction in which stapling fingers 262, 262′ extend awayfrom stapling base 264, in a manner that the staples may be consideredto curve back upon themselves thereby providing excellent securementtogether of tissue layers positioned between the two lips of theoperating capsule.

Referring to FIGS. 2, 27 and 29 through 31, in the preferred embodimentof the apparatus the invention further includes means for grabbingtissue, specifically lumen wall tissue, and pulling that lumen walltissue into operating capsule 12 so that the tissue may be cut andsutured thereby removing the diseased or otherwise undesirable tissuefrom the lumen wall. Two tissue grabbers are designated generally 194 inFIG. 2. While two such tissue grabbers have been illustrated and arepreferred, it is to be understood that only a single tissue grabber maybe provided or three or more tissue grabbers may be provided, dependingon the size in which the apparatus is constructed and the particularconditions to be treated using the apparatus.

Each tissue grabber 194 preferably includes a handle member designatedgenerally 196 where the handle member includes two preferably integrallyformed finger rings 198 and a thumb ring 200. Each tissue grabber 194further preferably includes a cable 202 where, similarly to the othercables described herein, cable 202 includes inner and outer portionsdenoted by subscripts “I” and “O” respectively; additionally, each cable202 further includes an, intermediate portion denoted by subscript “M”.

Thumb ring 200 is moveable axially relative to handle member 196 andspecifically relative to finger rings 198 in the direction indicated bydouble-ended arrow TR in FIG. 2. Finger rings 198 are fixed tointermediate portion 202 _(M) of cable 202. Thumb ring 200 is fixedlyconnected to inner portion 202, of cable 200.

At the ends of cable 202 opposite from finger rings 198 and thumb ring200, are two spring-loaded alligator clip-type members 204 which areconnected to inner portion 202, of cable 202. Alligator clip-typemembers 204 have two facing, preferably metallic jaws, each havingalligator-type teeth formed by serations on the facing portion of thejaw. Each jaw is designated 206 in the drawings.

The spring-loading of jaws 206 of alligator clip-type members 204results in jaws 206 opening as alligator clip-type members 204 areextended out of intermediate portions 202 _(M) of cable 202. Suchextension of alligator clip-type members 204 is effectuated by advancingthe thumb ring 200 relative to finger rings 198 thereby to advance innerportion 202 _(I) of cable 202 relative to intermediate portion 202 _(M).Intermediate portion 202 _(M) of cable 202 is preferably fabricated frommaterial having excellent memory characteristics so that the physicianor other attending health care professional can effectuate a desiredbend of cable 202, specifically of intermediate portion 202 _(M), andsuch bent intermediate portion 202 _(M) will retain such bend asintermediate portion 202 _(M) is advanced from or withdrawn into outerportion 202 _(O) of cable 202. The desired bend may be introduced tointermediate portion 202 _(M) manually prior to insertion of operatingcapsule 12 into the lumen of interest or may be effectuated during theoperating procedure by advancing intermediate and inner portions ofcable 202 until alligator clip-type members 204 contact one of the rigidinterior surfaces of operating capsule 12. Once such contact has beeneffectuated, continued advancement of intermediate and inner portions202 _(M), 202 _(I) of cable 202 will result in these portions of cable202 bending. Due to the memory characteristic of intermediate portion202 _(M), the bend will remain in intermediate and inner portions 202_(M), 202 _(I) of cable 22.

When the physician or other attending professional has positionedoperating capsule 12 at the desired location within the lumen and hasopened the operating capsule 12 thereby to provide access to theundesirable tissue to be removed, the lumen wall must be grasped andpulled into operating capsule 12 sufficiently far that all of thediseased or otherwise undesirable tissue is within operating capsule 12prior to the tissue suturing and cutting operation. This tissue pullingis preferably effectuated using tissue grabbers 194. Specifically, thephysician or other attending health care professional first preferablyadvances thumb rings 200 towards finger rings 198. This causes alligatorclip-type members 204 at the ends of inner portion 202, to extend out ofthe intermediate portion 202 _(M) of cable 202 with jaws 206 ofalligator members 204 opening due to the spring-loading thereof. Thephysician or other attending health care professional then moves thealligator clip-type members, with jaws 206 open, into position to graspthe lumen wall tissue at the desired locations. This is accomplished byadvancing finger ring 198 and thumb ring 200 together thereby advancinginner portion 202 _(I) and intermediate portion 202 _(M) of cables 202and alligator clip-type members 204 all unitarily, without moving thumbring 200 relative to finger ring 198.

Once the open jaws 206 of alligator clip-type members 204 are at thedesired positions, the physician or other attending health careprofessional advances finger ring 198 away from thumb ring 200 whilemaintaining thumb ring 200 at a fixed position. This movement of fingerring 198, which would be to the left in FIG. 2, causes the intermediateportion 202 _(M) of cable 202 to close about joined ends of jaws 206 ofspring-loaded alligator clip-type members 204, thereby closing jaws 206towards one another and entrapping tissue between the serrated jaws 206.

Once the tissue has been entrapped, the physician or other attendinghealth care professional moves finger ring 198 and thumb ring 200 to theright in FIG. 2, without moving finger ring 198 relative to thumb ring200. This effectively shortens the length of cables 202 which are withinoperating capsule 12 thereby drawing the gripped tissue into capsule 12.This is illustrated schematically in FIG. 31.

Once finger ring 198 and thumb ring 200 have been moved sufficiently farto the right in FIG. 2, without any relative notion therebetween, so asto draw the tissue into operating capsule 12 to the desired extent, thephysician or other attending health care professional grasps and movestrigger 36 relative to handle 32. This advances ramp-knife assembly 50along its path to the extent the operator moves trigger 36.

Advancement of ramp-knife assembly 50 along the path vertically advancesstaple support members 166 and staple support blocks 168, drivingstapling fingers 262, 262′ through tissue resting on planar uppersurface 88 of lower lip 28. Due to the configuration of ramp-knifeassembly 50 whereby ramp 82 effectuates vertical movement of staplesupport members 166 with ramp 82 preceeding knife portion 76 along thetissue, the tissue is stapled by the action of stapling fingers 262,262′ before being cut by knife portion 76.

Referring specifically to FIG. 31, lumenal wall tissue is designatedgenerally 208. The inner surface of the lumenal wall which is acontinuous interior surface prior to the tissue stapling and tissuecutting operations, is designated 210 while the outer surface of thelumenal wall is designated 212 in FIG. 31. The portion of the innersurface 210 of the lumenal wall tissue which has been grasped and drawninto operating capsule 12 is designated 210′.

In FIG. 31, configuration of the lumenal wall during the tissue staplingand cutting operation is shown. It is specifically to be noted that whenusing the apparatus of the invention and when practicing the methods ofthe invention, the lumenal wall may be drawn entirely into the operatingcapsule with lumenal wall tissue 208 folded upon itself as illustrated,so that when the lumenal wall tissue has, been drawn into the capsule,the exposed upper portion of tissue within operating capsule 12 and theexposed lower (or downwardly facing) portion of tissue within thecapsule are both from inner surface 210 of the lumenal wall 208. Theline denoting the lumenal wall tissue folded upon itself is designated214 in FIG. 31.

One major advantage afforded by the apparatus and methods of theinvention is that all of the tissue of the lumenal wall at a site ofinterest may be drawn into operating capsule 12 prior to the tissuesuturing and cutting operation. As a result, once the tissue suturingand cutting operation is complete, an entire section of lumenal wall hasbeen removed and is resident within the operating capsule. Wheremalignant tissue is being removed from a lumenal wall, this providesenhanced assurance that the resection of the tissue has successfullyremoved all of the malignant portion from the lumenal wall, ascontrasted to techniques where only the inner surface of the wall isremoved.

As is further apparent from FIG. 31, the tissue stapling function occursprior to the tissue cutting function. This is evident from the fact thatthe two lines of staples, which have stapled together thefolded-on-itself portion of the lumenal wall, are ahead of inclinedleading tissue cutting edge 78 of knife portion 76.

As yet another advantage afforded by the invention, the staplingoperation secures together healthy tissue in facing disposition along asite line removed from the line of tissue cutting. This results infaster healing at the wound site. Moreover, since tissue stapling isperformed outboard of the locale at which tissue cutting is performedand since the diseased or other undesirable tissue is retained inboardof the tissue cutting function, the probability of contamination ofhealthy tissue (by the resected undesirable and possibly malignanttissue which remains within operating capsule 12) is minimized.

When apparatus 10 is used in performing procedures in the colon or eventhe small intestine, typically tip extremity 218 and flexible tubulartransmission means 220 of endoscope 216 are fed through apparatus 10from control module 14 and exit operating capsule 12 via an aperture 238in upper shell portion 22 of operating capsule 12. Aperture 238 isillustrated in FIGS. 1B, 8, 9, 18 and 30.

Once endoscope 216 has been threaded through apparatus 10, if aprocedure is being performed in the colon, tip extremity 218 andflexible tubular transmission means 220 of endoscope 216 are introducedinto the colon via the rectum. The physician or other attending healthcare professional then proceeds, to guide tip portion 218 of endoscope216 up the colon by manually advancing flexible tubular transmissionmeans 220 into the rectum and controlling left/right and up/downmovement of tip portion 218 using motion control disk 228 and motioncontrol knob 230.

Once the physician or other attending health care professional haspositioned tip portion 218 where the tissue of interest is in view andtip portion 218 is sufficiently close to that tissue that the tissue maybe grasped and brought into the interior of operating capsule 12, thephysician or other attending health care professional then advancesoperating capsule 12 and flexible tubular member 16 along flexibletubular transmission means 220, into the patient's colon via the rectum.

The physician guides operating capsule 12 up the colon and alongflexible tubular transmission means 220 using directional control knobs40 and 42 of control module 14. The physician continues to advanceoperating capsule 12 and flexible tubular member 16 until operatingcapsule 12 arrives at tip extremity 218, where the malignant, diseasedor otherwise undesirable tissue to be resected is located.

Once operating capsule 12 is at this position, the physician withdrawsflexible tubular transmission means slightly from apparatus 10 therebywithdrawing tip extremity 218 from aperture 238 into the positionillustrated generally in FIG. 31 where tip extremity 218 is withinoperating capsule 12. With tip extremity 218 at this position, thephysician or other attending health care professional proceeds to usetissue grabbers 194 to grasp the colon wall tissue, drawing the colonwall tissue including the malignant, other diseased or otherwiseundesirable colon wall tissue into the interior of operating capsule 12,into a position generally illustrated in FIG. 31 where the malignant,other diseased or otherwise undesirable tissue is preferably entirelywithin the interior of operating capsule 12 and outer surface 212 oflumenal wall 208 is folded upon itself. Once the physician hasmanipulated the tissue into this position using tissue grabbers 194, thephysician actuates ramp-knife assembly 50 to perform the stapling andtissue cutting functions as illustrated in FIG. 31.

Once tissue stapling and cutting has been performed, operating capsule12 may be closed thereby to retain the malignant, other diseased orotherwise undesirable tissue in a position where it does not contact theremaining and presumably healthy lumenal wall tissue outside ofoperating capsule 12.

If desired, the physician may then advance tip extremity 218 andflexible tubular transmission means 220 of the endoscope 216 relative toapparatus 10 to cause tip extremity 218 to once again protrude fromaperture 238. The physician may then slightly withdraw apparatus 10,specifically operating capsule 12 and flexible tubular member 16,thereby removing operating capsule 12 from the immediate vicinity of thewound site. This permits the physician to inspect the wound site usingendoscope 16 by manipulating tip extremity 218 protruding out ofaperture 238. If the endoscope 216 is equipped with cauterizing heatersand if cauterizing of the stapled wound is necessary to prevent anyexcessive bleeding, this may be performed using endoscope 216 andparticularly tip extremity 218 protruding from aperture 238.

Once the surgical procedure has been completed and the physician issatisfied with the results, flexible tubular member 16 and operatingcapsule 12 are withdrawn from the colon. Flexible tubular transmissionmeans 220 of endoscope 216 may be simultaneously withdrawn in a unitarymotion with operating capsule 12 and flexible tubular member 16, or iffurther inspection of the wound site is desired, flexible tubulartransmission means 220 of endoscope 216 may be removed from the colonafter such further inspection has been performed.

While the foregoing description has discussed performing cauterizationof the wound using endoscope 216, it is within the purview of theinvention to provide separate cauterizing means as an accessory or anauxiliary item within operating capsule 12. Similarly, it is within thepurview of the invention to provide multiple ports, such as aperture238, for viewing the lumen interior where the surgical procedure isbeing performed.

Additionally, while the foregoing description has concentrated on use ofan endoscope such as endoscope 216 illustrated generally in thedrawings, it is within the purview of the invention to use apparatus 10together with a colonoscope or an ectoscope or to use apparatus 10 in acatheter guided fashion.

Operating capsule 12 may be constructed in various shapes differing fromthat illustrated in the drawings. Particularly, operating capsule 12 maybe constructed in the shape of a hemisphere of a football where thefootball has been divided in half along a vertical plane. In such case,aperature 238 might be provided at the point of the football.

Further respecting operating capsule 12, the opening between upper andlower shell portions 22, 24 need not be configured to be along thehorizontal mid point of operating capsule 12.

Tissue grabbers 194 have been illustrated as including finger rings 198and a thumb ring 200. Tissue grabbers 194 may equally well be providedwith trigger-like means for controlling or actuating the tissuegrabbers.

Further respecting tissue grabber means 194, while these means have beenillustrated with alligator-like jaws, the tissue grabbing function couldequally well be performed by suction cups with the necessary vacumnsupplied via the endoscope.

While cables and pulleys have been illustrated to control the operatingcapsule, chains, ratchets and gears may also be used.

Referring to FIG. 32, an alternate embodiment of an operating capsulemanifesting aspects of the invention is illustrated schematically wherethe operating capsule is designated generally 12′. In FIG. 32, theoperating capsule is illustrated divided into two parts, 12′₁ and 12′₂.The apparatus illustrated schematically in FIG. 32 is configured toendolumenally remove a cylindrical wall section of undesired lumenaltissue and to circumferentially secure the remaining lumenal wall tissuefrom either side about the site of cylindrical removal.

Further respecting FIG. 32, a flexible tubular transmission meansportion of a conventional endoscope is designated generally 220′ and isillustrated schematically as including a tip extremity portion 218′.

Operating capsule 12′ is configured generally cylindrically and, asillustrated, separates into two portions. Each portion of operatingcapsule 12′ includes tissue grabbers, only the jaws of which have beenillustrated schematically as 206′ in FIG. 32.

The respective cylindrical parts 12 ₁′ and 12 ₂′ have respective annularlips 27, 27′ associated therewith. Lips 27, 27′ are annular or circularand are made to be closely spaced one from another in a manner similarto upper and lower lips 26, 28 in the preferred embodiment of theapparatus described above. One of lips 27, 27′ is equipped with tissuestapling or suturing and tissue cutting means of the same general typeas illustrated in FIGS. 18 through 24, while the remaining one of lips27, 27′ is equipped with anvil surface means of the type generallyillustrated in FIGS. 24 and 26. The tissue cutting means is preferablyradially inboard of the tissue stapling or suturing means in lip 27 or27′.

Further illustrated in FIG. 32 is a lumenal wall 208′ which is generallycylindrical in configuration. As illustrated in FIG. 32, an annular orcylindrical portion 209 of lumenal wall tissue 208′ has been drawn intoa position at which cylindrical section 209 of lumenal wall tissue 208is configured with a smaller diameter than lumenal wall tissuecylindrical portion 208′. As such, cylindrical lumenal wall portion 209has a diameter sufficiently less than the diameter of operating capsule12′ that cylindrical lumenal wall portion 209 is completely within acylindrical envelop defined by the interior of operating capsule 12′.Lumenal wall 208 is drawn into this position using tissue grabbers 206′.

Once lumenal wall 208′ and cylindrical section thereof 209 are in theposition illustrated in FIG. 32, the two parts 12′₁ and 12′₂ ofoperating capsule 12′ are brought together to position lips 27, 27′ inclose proximity to one another. At this position, the tissue stapling orsuturing means and tissue cutting means are actuated thereby suturingtogether circular or annular portions of lumenal wall denoted 350 whichare trapped between lips 27, 27′. The stapling or suturing apparatus isconfigured to actuate all of the staples or sutures located aroundcircular lip 27 or 27′ simultaneously so that annular portions 350 oflumenal wall tissue are stapled or sutured together around the completecircle defined by lips 27, 27′ at one time.

Once the tissue suturing or stapling and tissue cutting operations havebeen performed, cylindrical section 209 of lumenal wall tissue 208 isretained within operating capsule 12′ whereupon operating capsule 12′ isremoved from the lumen. The lumenal wall tissue remains, having had acylindrical section removed therefrom, with an annular, 360° line ofsuturing or staples securing together portions of cylindrical lumenalwall 208′ from which cylindrical wall section 209 has been removed.

Operation of operating capsule portions 12′₁ and 12′₂ is effectuatedusing cables, an operating control module and a flexible cable carryingmember such as illustrated in FIGS. 1 through 31. A radiallyforeshortened version of flexible cable carrying member 16 may beprovided about endoscope 220′, between operating capsule sections 12′₁and 12′₂, to carry cables between the two sections 12′₁ and 12′₂ of theoperating capsule 12′ in order to close cylindrical sections 12′₁ and12′₂ of the operating capsule 12′ upon one another to bring lips 27, 27′into proximity with one another, to be in position to effectuate thetissue securement and cutting functions.

While the preferred embodiments of the invention have been describedabove and alternative embodiments have also been described, the scope ofprotection to which the invention is believed entitled is defined by theclaims and by equivalents thereto which perform substantially the samefunction in substantially the same way to achieve substantially the sameresult as set forth in the claims, so long as such substantialequivalents, as defined by a claim for such substantial equivalent, donot read on the prior art.

1-35. (canceled)
 36. An apparatus for performing an intralumenalprocedure, comprising: an endolumenal operating capsule comprising aplurality of staple receiving slots formed in a lip extending along alongitudinally elongated portion of said capsule and a stapleadvancement member movable along the lip, for driving staples from thestaple receiving slots through tissue positioned adjacent thereto; acontrol handle remaining outside the body for receiving tactile motionsof an operator corresponding to a desired positioning of the capsule;first and second substantially coaxial flexible sheaths extending fromthe capsule to the control module; first and second control wiresextending in an annular space between the first and second sheaths fromthe capsule to the control module to transmit forces from the controlhandle to the capsule; and a coupling between the first and secondsheaths maintaining the first and second control wires in acircumferentially spaced relation to one another so that forcetransmitted by the control wires follows a desired path and limits adegree of bending of the first and second sheaths within a desiredrange.
 37. The apparatus of claim 36, wherein the coupling between thefirst and second sheaths includes a plurality of serially engagingdisks, each disk further comprising a substantially conical centralportion having an axial aperture therein extending around the firstsheath and an annular flange at a base of the conical portion includinga plurality of radial apertures extending radially inward from aperiphery of the flange, an exterior of the conical portion extendingthrough an annular flange and fitting into a hollow conical portion ofan adjacent disk.
 38. An apparatus for performing an intralumenalprocedure on a lumen wall of a lumen, comprising: an endolumenaloperating capsule comprising a plurality of staple receiving slotsformed in a lip extending along a longitudinally elongated portion ofsaid capsule and a staple advancement member movable along the lip, fordriving staples from the staple receiving slots through tissuepositioned adjacent thereto; a control module which remains outside thebody for receiving tactile motions of an operator to generate signalsindicative of a desired positioning of the capsule; first and secondsubstantially coaxial flexible sheaths extending from the capsule to thecontrol module; first and second control wires extending in an annularspace between the first and second sheaths from the capsule to thecontrol module, the first and second control wires positioning thecapsule along and within a body lumen by transmitting forces appliedmanually thereto via the control module along a curvilinear path as thefirst and second sheaths bend to define the curvilinear path whilelimiting curvilinear bending of the first and second sheaths to apreselected degree; and a coupling between the first and second sheathsmaintaining the first and second control wires in circumferentiallyspaced relation to one another so that force transmitted by the controlwires follows a desired path to limit a degree of bending of the firstand second sheaths within a desired range.
 39. A method for positioninglumenal tissue for an endolumenal cylindrical resectioning comprising:a. inserting a tissue suturing instrument into a body lumen through anaturally occurring body orifice; b. advancing the instrument within thelumen to an area of tissue to be cylindrically resectioned; c. drawingthe tissue to be resectioned into an annular cutting zone of theinstrument; d. stapling tissue an annular margin of tissue surroundingthe tissue to be resectioned; and e. resecting the tissue within thecutting zone.
 40. The method of claim 39, further comprising staplingthe annular margin of tissue substantially simultaneously around theentire circumference of the lumen.
 41. A surgical device, comprising: anoperating capsule, the operating capsule including a staple assembly; acontrol module; and a flexible tube having a distal end and a proximalend, wherein the distal end is connected to the operating capsule andthe proximal end is connected to the control module, the flexible tubeincluding an outer sheath; and a plurality of disks disposed within theouter sheath, each of the disks being substantially conical andincluding an inner aperture extending therethrough.
 42. The surgicaldevice according to claim 41, wherein each of the plurality of disksincludes a convex exterior surface and a hollow concave interior. 43.The surgical device according to claim 42, wherein the flexible tubefurther includes an inner sheath at least partly disposed within theinner apertures of the disks.
 44. A surgical device, comprising: anoperating capsule, the operating capsule including a staple assembly; acontrol module; a flexible tube having a distal end and a proximal end,wherein the distal end is connected to the operating capsule and theproximal end is connected to the control module, the flexible tubeincluding an outer sheath; and a control wire disposed within theflexible tube, a proximal end of the control wire being connected to thecontrol module with a distal end of the control wire connected to theoperating capsule, the control module actuating the staple assembly viathe control wire.
 45. The surgical device according to claim 44, whereinthe flexible tube includes an outer sheath and a plurality of disksdisposed within the outer sheath, the control wire being disposed withinthe outer sheath.
 46. The surgical device according to claim 45, whereineach of the plurality of disks is shaped substantially as a hollow conehaving an inner aperture extending therethrough.
 47. A surgical device,comprising: an operating capsule including a staple assembly and atleast one tissue clip; a control module; and a flexible tube having adistal end connected to the operating capsule and a proximal endconnected to the control module, the flexible tube including an outersheath and a plurality of disks disposed within the outer sheath, eachof the plurality of disks being shaped substantially as a hollow coneincluding an inner aperture extending therethrough.
 48. The surgicaldevice according to claim 47, wherein each of the plurality of disksincludes a convex exterior surface and a concave interior surface. 49.The surgical device according to claim 48, wherein the flexible tubefurther includes an inner sheath at least partly disposed within theinner apertures of the disks.
 50. A surgical device, comprising: anoperating capsule, the operating capsule including a staple assembly andat least one tissue clip; a control module; a flexible tube having adistal end connected to the operating capsule and a proximal endconnected to the control module; a control wire disposed within theflexible tube, a proximal end of the control wire being connected to thecontrol module and a distal end of the control wire being connected tothe operating capsule so that the control module actuates the stapleassembly via the control wire; and a clip cable disposed within theflexible tube, a proximal end of the clip cable being connected to thecontrol module and a distal end of the clip cable being connected to thetissue clip so that the control module actuates the tissue clip via theclip cable.
 51. The surgical device according to claim 50, wherein theflexible tube includes an outer sheath and a plurality of disks disposedwithin the outer sheath, the control wire and clip cable being disposedwithin the outer sheath.
 52. The surgical device according to claim 51,wherein each of the plurality of disks is shaped substantially as ahollow cone having an inner aperture extending therethrough.
 53. Amethod for performing a procedure on lumenal tissue comprising:inserting a tissue suturing instrument into a body lumen via a naturallyoccurring body orifice; advancing the instrument within the lumen to anarea of tissue to be resectioned; drawing the tissue to be resectionedinto a cutting zone of the instrument by grasping the lumenal wallinterior on respective sides of the tissue to be resected to fold thetissue against itself; and stapling the folded tissue surrounding thetissue to be resected to close an orifice which would otherwise resultfrom removal.
 54. An apparatus for resecting tissue within a body lumen,comprising: an operating capsule including a structure for selectivelycoupling to a flexible endoscope, the operating capsule being sized sothat, when in an operative position entirely located within the bodylumen adjacent to a portion of tissue to be resected, structuralintegrity of lumenal tissue is maintained, the operating capsuleincluding a suturing assembly and defining a cutting zone adjacent tothe suturing assembly; a control handle which, when the capsule isinserted into the body lumen, remains outside the body; a flexiblemember which, when the operating capsule is in an operative positionwithin the body lumen, extends through the body and out a natural bodyorifice to the control handle; a tissue grabber grasping a fullthickness fold of tissue including the tissue to be resected and drawingthe fold of tissue into the cutting zone for suturing by the suturingassembly; and a knife cutting away from the sutured fold of tissue, theportion of tissue to be resected.